Clinical Trials

Roche has announced data from stage 1 of the National Institutes of Health (NIH)-sponsored phase 3 OUtMATCH trial, which assessed the safety and efficacy of Xolair (omalizumab) in patients allergic to peanuts and at least two other common foods.

The results were published in the New England Journal of Medicine (NEJM)andfeaturedinasymposium at the 2024 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.

The trial demonstrated that treatment with Xolair increased the amount of allergen that it took to cause moderate-to-severe allergic reactions in multi-food allergic people as young as one-year. The allergens included peanuts, milk, egg, wheat and tree nuts (cashew, hazelnut and walnut).

Robert Wood MD, director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center, US, and principal investigator on the study, commented: “Over the past 35 years, I have seen how debilitating food allergies can be for patients and their loved ones, as they are consumed by the fear of accidental exposure. While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy. The results of the OUtMATCH study showed that anti-IgE therapy could significantly reduce the occurrence of allergic reactions across multiple foods in the event of an accidental exposure.”

Levi Garraway MD PhD, Roche’s chief medical officer and head of global product development, added: “The phase 3 OUtMATCH results represent a major advance and reinforce our commitment to addressing critical gaps in care for conditions like food allergy.

Now recently FDA-approved, Xolair provides a new way to help manage food allergies for children and adults who live with the constant fear of life-threatening allergic reactions.”